| 药品注册报批生产工艺与上市生产工艺保持一致性探讨 |
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| 引用本文： | 党晓伟,陈玉文.药品注册报批生产工艺与上市生产工艺保持一致性探讨[J].中国执业药师,2011,8(4):39-40. |
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| 作者姓名： | 党晓伟 陈玉文 |
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| 作者单位： | 1. 沈阳药科大学工商管理学院,辽宁,沈阳,110016;承德护理职业学院生理药理室,河北,承德,067000
2. 沈阳药科大学工商管理学院,辽宁,沈阳,110016 |
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| 摘 要： | 针对我国新修订药品GMP中对药品注册与上市生产工艺保持一致性的要求,对企业目前所存在的缺陷和不足进行分析探讨,为药品生产企业顺利实施新修订版本GMP提供参考。
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| 关 键 词： | 药品生产质量管理规范 生产工艺 一致性 |
Discussion on Maintaining Consistency of Production Technology Used for Drug Registration Approval and for Manufacturing of Products to be Marketed |
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| Authors: | Dang Xiaowei Chen Yuwen |
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| Institution: | 1 Business Administration School of Shenyang Pharmaceutical University,Liaoning Shenyang 110016,China;2 Physiological and Pharmacological Laboratory of Chengde Nursing Vocational College,Hebei Chengde 067000,China) |
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| Abstract: | This paper discussed and analyzed the defects and problems existed in the drug enterprises according to the requirements of newly revised GMP in the aspect of keeping consistency of production technology used for drug registration approval and for manufacturing of products to be marketed,so as to provide references for implementation of the newly revised GMP smoothly. |
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| Keywords: | GMP Production Technology Consistency |
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